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EQUALINE TOLNAFTATE ANTIFUNGAL

Dosage form: cream
Ingredients: TOLNAFTATE 10mg in 1g
Labeler: SUPERVALU INC
NDC Code: 41163-251

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient                                                                              Purpose

Tolnaftate 1% .............................................................................. Antifungal

Uses

  • proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • proven effective in the prevention of athlete's foot with daily use
  • for effective relief of itching, burning and cracking

Warnings

For external use only

When using this product avoid contact with the eyes.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Wash affected area and dry thoroughly
  • Apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
  • Supervise children in the use of this product
  • For athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • Use daily for 4 weeks; if condition persists longer, ask a doctor
  • To prevent athlete's foot, apply once or twice daily (morning and/or night)
  • This product is not effective on the scalp or nails

Other Information

  • Store between 20o to 25oC (68o to 77oF)
  • Lot No. & Exp. Date: see box or see crimp of tube

Inactive ingredients

butylated hydroxytoluene, cetanol, ceteth-20, liquid paraffin, methylparaben, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearly alcohol

DISTRIBUTED BY

SUPERVALU INC.

EDEN PRAIRIE,

MN 55344 USA

MADE IN KOREA



EQUALINE TOLNAFTATE ANTIFUNGAL 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-251
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
CETETH-20 
PARAFFIN 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SORBITAN MONOSTEARATE 
STEARYL ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:41163-251-461 TUBE in 1 CARTON
114 g in 1 TUBE
2NDC:41163-251-471 TUBE in 1 CARTON
228 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/28/2011
Labeler - SUPERVALU INC (006961411)
Registrant - UNITED EXCHANGE CORP. (840130579)
Establishment
NameAddressID/FEIOperations
Taiguk Pharm. Co., Ltd._Buyeo branch689060246manufacture(41163-251)

Revised: 01/2015
 
SUPERVALU INC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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